FEATURED EDITORIAL
Just like inspecting a house before a major renovation, biopharmas must address underlying bispecific structural and analytical flaws before handing their molecule off to a CDMO.
- Outsourcing Growth, And The Cold (Storage Monitoring) Truth
- CSV Assumes The AI System Sits Still — It Doesn't.
- Lower Court Agrees With WuXi AppTec (And Many Of Us)
- Mission-Driven Professionals And Students Build America's Supply Chains
- July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
- In Bioprocessing, Trusted Data Is A Process Variable
- Combination Cell Therapy's Clinical Success Hinges On Manufacturability
GUEST COLUMNISTS
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July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.
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In Bioprocessing, Trusted Data Is A Process Variable
As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.
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Combination Cell Therapy's Clinical Success Hinges On Manufacturability
Cell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.
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Are Biopharma Companies Outsourcing Their Ability To Think?
Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.
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June 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
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The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.
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Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
Version-controlled quality target product profiles, authored by the drug sponsor, close any gaps between the CDMO's and sponsor's definitions of quality.
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Reshoring Pressure Meets Manufacturing Reality
U.S. pharma can't reshore what domestic capacity can't absorb. Senior leaders from Takeda, Biogen, Eli Lilly, and others reveal why tariff pressure is colliding with a sterile fill-finish shortage, workforce gaps, and ADC capacity bottlenecks.
PHARMA OUTSOURCING WHITE PAPERS
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Stabilizing Your Supply Chain In Times Of Global Volatility
Discover how a proactive, risk-based supply chain strategy can help strengthen resilience, mitigate disruption, and ensure continuity across your biotech and pharmaceutical operations.
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Super Short Activated CAR-T Process
Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.
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Set Your Cell And Gene Therapy Program Up For Success From Day One
Partner with a specialized CDMO early in your CGT development to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.
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EMA Support For Rare Disease Therapies
Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.
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Sterile Filtration Of Budesonide As A Preferred Sterilization Strategy
Accelerate development of high‑quality inhalation therapies by leveraging sterile‑filtered budesonide to safeguard purity, stability, and patient safety.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
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ON-DEMAND WEBINARS
- When Unexpected Particles Threaten Your Biologic
- Life Cycle Assessment (LCA): Empowering Sustainable Decisions
- Controlling Nitrosamine Risk In Drug Products: Detection, Formation, And Control Strategies
- Enhancing AAV Manufacturing Yield Via Mini-Helper Plasmid
- When High-Stakes ADC Decisions Can't Wait for More Material or Better Data